MULTIGENT ABBOTT VANCOMYCIN ASSAY 6E44-21

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-29 for MULTIGENT ABBOTT VANCOMYCIN ASSAY 6E44-21 manufactured by Microgenics Corporation.

Event Text Entries

[125593179] Ivd test for vancomycin revealed unusually low result.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3010939897-2018-00003
MDR Report Key8017680
Date Received2018-10-29
Date of Report2018-10-01
Date of Event2018-09-21
Date Mfgr Received2018-09-26
Date Added to Maude2018-10-29
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. DAVE SCHULTENOVER
Manufacturer Street46500 KATO ROAD
Manufacturer CityFREMONT CA 94538
Manufacturer CountryUS
Manufacturer Postal94538
Manufacturer Phone5109795000
Manufacturer G1MICROGENICS CORPORATION
Manufacturer Street46500 KATO ROAD
Manufacturer CityFREMONT CA 94538
Manufacturer CountryUS
Manufacturer Postal Code94538
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameMULTIGENT ABBOTT VANCOMYCIN ASSAY
Generic NameVANCOMYCIN TEST SYSTEM
Product CodeLEH
Date Received2018-10-29
Model Number6E44-21
Catalog Number6E44-21
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMICROGENICS CORPORATION
Manufacturer Address46500 KATO ROAD FREMONT CA 94538 US 94538


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-10-29

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